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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
A 43-year-old man developed nausea and vomiting during off label treatment with ribavirin; additionally, he developed COVID-19 infection during immunosuppressive therapy with prednisolone, rituximab and mycophenolate-mofetil. He received off label treatment with lopinavir/ritonavir, oseltamivir, immune-globulin and hydroxychloroquine for COVID-19 [routes, durations of treatments to reactions onsets and outcomes not stated]
The man presented in August 2019 with oral blisters and conjunctivitis for 4 months. Subsequently, he was diagnosed with mucous membrane pemphigoid (MMP). Therefore, in December 2019, he was commenced on prednisolone 50mg along with rituximab 500mg weekly for four weeks. However, his eye condition worsened, and despite receiving prednisolone 30mg, his conjunctival adhesions were rapidly developing. Therefore, on 7 February 2020, he started receiving mycophenolate-mofetil 2 g/day, and high-dose of immune-globulin was planned. However, on 9 March 2020, he reported chills, malaise, fever, mild dyspnoea and dry cough for one week. He had a significant medical history for hypertension, diabetes and benign prostatic hypertrophy, for which he had been receiving metformin, losartan, triamterene, finasteride, tamsulosin and bisoprolol. His lungs were clear; however, oxygen saturation was 75%. After admission, mycophenolate-mofetil was stopped and prednisolone was tapered to 15mg. On day 1, he received immune-globulin 30g along with oseltamivir 75mg two times a day and hydroxychloroquine 400 mg/stat. His body temperature was 39°C, pulse rate was 106 /min, C-reactive protein was positive, BP was 120/80 mmHg, respiratory rate was 22 /min. On subsequent day, lopinavir/ritonavir 400/100mg two times a day along with meropenem and vancomycin for possible staphylococcal pneumonia were added to therapy. He continued on same therapy on day 3. However, on day 4, ribavirin 2.4 g/day was added to previous therapy. Subsequently, meropenem and vancomycin therapy was switched to levofloxacin. He developed ribavirin-related nausea and vomiting, and ribavirin was stopped on day 7. On day 7, his temperature was 37.1°C, pulse rate was 92 /min, BP was 120/80 mmHg, respiratory rate was 16 /min, oxygen saturation was 94%. His spiral CT scan showed peripheral multilobular opacity, and ground-glass appearance consistent with COVID-19. Eventually, the man was discharged on day 7 with marked improvement. His eye condition improved markedly, and COVID-19 and lymphopenia resolved completely.